van der Molen T, Sears M R, de Graaff C S, Postma D S, Meyboom-de Jong B
Groningen University, The Netherlands.
Eur Respir J. 1998 Jul;12(1):30-4. doi: 10.1183/09031936.98.12010030.
This study aimed to investigate the effect of treating patients with moderate asthma with formoterol on quality of life (QoL) and to compare several questionnaires in their ability to detect changes in QoL. In an eight month multicentre, randomized, placebo-controlled trial, patients with asthma using daily inhaled corticosteroids and beta2-agonists (> or = 5 inhalations x week(-1)) were randomized to 6 months treatment with formoterol 24 microg b.i.d. (by Turbuhaler) or a matching placebo. Patients recorded symptoms (maximal score 21) and peak expiratory flow (PEF) twice daily. QoL was measured with two asthma-specific questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Living with Asthma Questionnaire (LWAQ), and with two generic QoL forms, i.e. the Short Form 36 (SF36) and the Psychological and General Well-Being scale (PGWB) at randomization and after 6 months of treatment. Out of 110 patients studied, 56 received formoterol and 54 placebo. Mean baseline forced expiratory volume in one second was 65% predicted. Mean morning PEF was 369 L x min(-1). Mean total symptom score was 3.6. Morning PEF increased (26.8 L x min(-1), p=0.0001) and symptoms decreased (-1.23, p=0.012) in the formoterol group in contrast to placebo. QoL improvements were measured in the LWAQ total score (baseline 0.61, change -0.05, p=0.048) and the physical construct of the LWAQ (baseline 0.71, change 0.07, p=0.044). The AQLQ and the generic QoL instruments showed no significant changes. In conclusion, the improvement in quality of life reported after 6 months was very small and only reflected by the Living with Asthma Questionnaire.
本研究旨在调查福莫特罗治疗中度哮喘患者对生活质量（QoL）的影响，并比较几种问卷检测生活质量变化的能力。在一项为期8个月的多中心、随机、安慰剂对照试验中，使用每日吸入糖皮质激素和β2受体激动剂（≥5次吸入/周）的哮喘患者被随机分为两组，一组接受为期6个月的福莫特罗24微克每日两次（通过都保）治疗，另一组接受匹配的安慰剂治疗。患者每天记录症状（最高得分21分）和呼气峰值流速（PEF）两次。在随机分组时和治疗6个月后，使用两种哮喘特异性问卷，即哮喘生活质量问卷（AQLQ）和哮喘患者生活问卷（LWAQ），以及两种通用生活质量量表，即简明健康状况调查量表（SF36）和心理与总体幸福感量表（PGWB）来测量生活质量。在研究的110名患者中，56名接受福莫特罗治疗，54名接受安慰剂治疗。一秒用力呼气容积的平均基线值为预测值的65%。平均晨PEF为369升/分钟。平均总症状评分为3.6分。与安慰剂组相比，福莫特罗组的晨PEF升高（26.8升/分钟，p = 0.0001），症状减轻（-1.23，p = 0.012）。LWAQ总分（基线0.61，变化-0.05，p = 0.048）和LWAQ的身体维度（基线0.71，变化0.07，p = 0.044）的生活质量有所改善。AQLQ和通用生活质量工具未显示出显著变化。总之，6个月后报告的生活质量改善非常小，仅在哮喘患者生活问卷中有所体现。
